Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

Breast Cancer Clinical Trial

Official title:

A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703585
• Other study ID #: MATCH-001
• Status: Completed
• Start date: October 4, 2012
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.

Description:

As part of the study, patients will have archival tumor tissue collected, and have tumor biopsies and blood samples taken. The samples will be tested for genetic alterations, and the results will be discussed with the patient including potential treatments. If patients agree, after they have received treatment for their cancer and their disease progresses, a second biopsy procedure will be done.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy.

• At least one biopsiable lesion deemed medically accessible and safe to biopsy.

• Candidate for one or more phase I or II clinical trials at the time of study enrollment or at a later time point.

• Fulfills local institution's laboratory parameters for tumor biopsy.

• Willingness and ability of patient to provide signed voluntary informed consent.

Exclusion Criteria:

• Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.

• Any contraindication to undergoing a biopsy procedure.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Eligible for Phase I or Phase II Study
• Gynecological Cancer
• Melanoma Cancer
• Metastatic

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Ontario Institute for Cancer Research, Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.		2 years
Secondary	The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90%		2 years
Secondary	The rate of acceptable tumor samples from fresh fine needle biopsy samples/total number of fresh fine needle biopsy samples greater than or equal to 50%		2 years
Secondary	Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%	Sequenom or MiSeq/TSCAP and MiSeq/NGS	2 years
Secondary	Analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples from time from patient recruitment to final results, less than a defined period of time, in greater than or equal to 90%	Sequenom or MiSeq/TSCAP analysis from fresh core needle biopsy samples less than 4 weeks; sequenom or MiSeq/TSCAP analysis from fresh fine needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh core needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh fine needle biopsy samples less than 8 weeks	2 years
Secondary	Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%		2 years